Effects of Gait Retraining With Auditory Feedback

NCT ID: NCT04302961

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-06-30

Brief Summary

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There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.

Detailed Description

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Conditions

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Ankle Injuries Ankle Inversion Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Auditory Feedback

Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback.

Group Type EXPERIMENTAL

Auditory Feedback

Intervention Type OTHER

Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.

No Feedback

Participants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving feedback.

Group Type ACTIVE_COMPARATOR

No Feedback

Intervention Type OTHER

Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.

Interventions

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Auditory Feedback

Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.

Intervention Type OTHER

No Feedback

Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* History of at least one ankle sprain
* Index ankle sprain \> 12 months prior to study enrollment
* Most recent ankle sprain \> 12 weeks prior to study enrollment
* Score \>10 on the Identification of Functional Ankle Instability (IdFAI) survey.
* Score \<95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a \<85% on the Sport subscales
* Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion Criteria

* History of ankle surgery
* History of other musculoskeletal injuries within the past 6 weeks
* Any condition affecting plantar pressure distribution
* Neurological or vestibular disorders affecting balance
* Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Charlotte

OTHER

Sponsor Role lead

Responsible Party

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Luke Donovan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UNC Charlotte

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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Torp DM, Thomas AC, Hubbard-Turner T, Donovan L. Plantar pressure profile during walking is associated with talar cartilage characteristics in individuals with chronic ankle instability. Clin Biomech (Bristol). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.

Reference Type DERIVED
PMID: 35504121 (View on PubMed)

Other Identifiers

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19-0552

Identifier Type: -

Identifier Source: org_study_id

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